The application portal for inclusion in the Health App Directory at the Federal Office for Drugs and Medical Devices (BfArM) in Germany has been online since May 27, 2020. The first reimbursable health apps were introduced on the Directory in early October 2020.
The manufacturer applies for the reimbursement (inclusion of the app on the Health App Directory) using the application form to the BfArM. If the manufacturer cannot immediately prove the benefit, but the method is promising and has the potential to prove benefits, a testing trial with a temporary listing in the Directory can be activated on application from a manufacturer (Fast Track procedure).
As of May 27, 2021, a total of 74 applications were received, 51 (69%) of which for provisional listing and 23 (31%) for final listing. Fifteen applications (20%) were introduced on the Directory, the negative decision was made for four applications (5%), 31 applications (42%) were withdrawn, and 24 (32%) are currently being processed.
The full details in German can be found here.
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